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Director, Clinical Sciences

Company: Ascent Services Group
Location: San Francisco
Posted on: February 25, 2021

Job Description:

Director, Clinical Sciences--(South San Francisco)
Direct Hire The Director, Clinical Sciences is a key cross-functional team member contributing to the design and execution of our--clinical trials. The Clinical Scientist is responsible for analyzing and interpreting study data (trial and individual patient level) and translating clinical data across and within the programs and studies. They also ensure that all studies are conducted with the highest level of ethical and safety standards and follow GCP and all regulatory policies. This team member will provide expertise to internal teams (CMC, clinical operations, regulatory affairs, non-clinical, medical writing, biometrics, and pharmacovigilance) and external teams (CROs, consultants) to ensure that Clinical Development scientific and medical strategies are met. The Director, Clinical Sciences will work closely with the Chief Medical Officer and VP of Clinical Development to ensure the integrity and success of our clinical trials. Open, effective, and proactive communication of the clinical development activities is critical for success in this role. Must have an excellent understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization). Thorough understanding of the drug development process from pre-IND through registration and post-registration desirable. Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have strong work ethics and be able to work independently and productively. Must be willing to travel up to 25%. Responsibilities

  • Contribute to the design, implementation and review of clinical protocols and study reports for scientific and operational accuracy
  • Contribute to the design, start-up, execution, analysis, and communication of the clinical studies for a product candidate
  • In collaboration with Clinical Operation and Statistics, responsible for timely delivery of high-quality clinical study data analysis; present clinical study results to the cross functional team and to the company Senior Management Team and external stakeholders
  • Work very closely with study investigators to ensure timely and high-quality execution of clinical studies
  • Work with KOLs to review clinical data and develop clinical development strategy
  • Collaborate with Clinical Operations to expedite execution of clinical trials
  • Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge to support a robust clinical development strategy
  • Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO and field team on developing robust studyprotocols, drive site selection, and patient recruitment programs that deliver enrollment Performs site monitoring with field team, as needed
  • Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRF's, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, and CSRs
  • Assist with the development of study presentations, handouts, and coordination of Investigator Meetings
  • Analyze data and assist in writing for publications and scientific presentations
  • In cooperation with Clinical Operations and Finance, develop and effectively manage annual budget for clinical activities Qualifications
    • Ph.D. in biology/bioengineering/biochemistry field with prior experience managing oncology trials; A Master's degree may be considered with supporting industry experience
    • The candidate should have a minimum of 10 years of clinical research experience in domestic and international clinical trials, oncology trial experience is preferred
    • Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations
    • Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward
    • Excellent written and oral communication and presentation skills
    • The ability to manage multiple priorities, while maintaining attention to detail is critical
    • Experience operating effectively within a matrixed environment, specifically in a healthcare biotech/pharmaceutical start-up setting
    • Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
    • Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels
    • Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms) Job Type: Direct Placement
      Location: South San Francisco, CA
      Job ID: 20-09216
      Date Updated: December 28, 2020 Deborah Ward is recruiting for this position. Corporate Office
      1001 Galaxy Way, Suite 405
      Concord, CA 94520
      925-627-4900 Employment Verifications
      Via The Work Number, employer code 105779 Additional office locations in Chico, CA; Chicago, IL; Los Angeles, CA.

Keywords: Ascent Services Group, San Francisco , Director, Clinical Sciences, Executive , San Francisco, California

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